A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: AL002; Drug: Placebo

• Registration Number: NCT04592874
• Lead Sponsor: Alector Inc.

Brief Summary

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Detailed Description

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2021-01-22
• Primary Completion: 2024-08-19
• Study Completion: 2024-09-12
• Status Verified: 2025-08
• Results First Submitted: 2025-08-18
• Results First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Results First Posted: 2025-10-29
• Last Update Posted: 2025-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
• MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
• Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
• Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

Exclusion Criteria

• Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
• Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
• Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
• History or evidence of clinically significant brain disease other than AD.
• Females who are pregnant or breastfeeding, or planning to conceive within the study period.
• Any experimental vaccine or gene therapy.
• History of unresolved cancer.
• Current use of anticoagulant medications.
• Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
• Participant is positive for presence of APOE e4/e4 genotype.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL002 Dose 2	AL002	AL002 every 4 weeks
Placebo	Placebo	Placebo every 4 weeks
AL002 Dose 1	AL002	AL002 every 4 weeks
AL002 Dose 3	AL002	AL002 every 4 weeks

Primary Outcome Measures

Name	Time	Method
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Study completion up to 96 weeks	Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96.; The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.

Secondary Outcome Measures

Name	Time	Method
Change in Mini-Mental Status Examination (MMSE) Score	Study completion up to 96 weeks	Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96; The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score	Study completion up to 96 weeks	Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96; The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96; The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96; The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.
Change in Alzheimer's Disease Composite Score (ADCOMS) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96; The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.

Trial Locations

Locations (87)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Woodlands Research Network, LLC - ERG; 🇺🇸 Rogers, Arkansas, United States

ATP Clinical Research; 🇺🇸 Costa Mesa, California, United States

Georgetown University Medical Center; 🇺🇸 Washington D.C., District of Columbia, United States

South Florida Neurology Associates; 🇺🇸 Boca Raton, Florida, United States

Brain Matters Research - ERG; 🇺🇸 Delray Beach, Florida, United States

Charter Research; 🇺🇸 Lady Lake, Florida, United States

ClinCloud, LLC; 🇺🇸 Maitland, Florida, United States

K2 Medical Research; 🇺🇸 Maitland, Florida, United States

K2 Winter Garden Ocoee; 🇺🇸 Ocoee, Florida, United States

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